EP0810001A1 - Dispositif de traitement des troubles pour vider la vessie chez l'homme et la femme - Google Patents

Dispositif de traitement des troubles pour vider la vessie chez l'homme et la femme Download PDF

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Publication number
EP0810001A1
EP0810001A1 EP97108525A EP97108525A EP0810001A1 EP 0810001 A1 EP0810001 A1 EP 0810001A1 EP 97108525 A EP97108525 A EP 97108525A EP 97108525 A EP97108525 A EP 97108525A EP 0810001 A1 EP0810001 A1 EP 0810001A1
Authority
EP
European Patent Office
Prior art keywords
catheter
balloon
valve
distal
end section
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP97108525A
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German (de)
English (en)
Other versions
EP0810001B1 (fr
Inventor
Konrad Dr. Engel
Kilian Engel
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Individual
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Individual
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Publication date
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Publication of EP0810001A1 publication Critical patent/EP0810001A1/fr
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Publication of EP0810001B1 publication Critical patent/EP0810001B1/fr
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Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0022—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed deep in the body opening
    • A61F2/0027—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed deep in the body opening inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/25—Artificial sphincters and devices for controlling urinary incontinence

Definitions

  • urine collection systems with urine bags (urinals) or absorbent aids (disposable diapers) worn on the outside of the body are known for both sexes, which serve to collect the urine and cause skin irritation through the urine, odor nuisance and thus social isolation.
  • a device for female incontinence is also known, the urinary bladder being emptied via a short catheter protruding from the urethra by manual actuation of a valve in the vaginal vestibule (EP 0407 218 A1).
  • the valve in the vaginal atrium is likely to lead to colonization of the device by vaginal atrial bacteria.
  • a fluid-fillable second balloon is arranged distal of the balloon and, when the catheter is in place, lies outside the sphincter muscle in the urethra and in this way prevents the catheter from being moved unintentionally into the interior of the bladder.
  • the length of the catheter is dimensioned such that its distal end is completely accommodated in the penis in the inserted state, and a valve is arranged in the distal end section which can be felt from outside through the wall of the urethra in the penis area.
  • the valve is, for example, a beak, Lip, ball or slide valve, the normally closed state of which can be converted into the open state by pressure between two fingers, so that micturition can take place.
  • this object is achieved with a device of the type mentioned at the outset by the design of the device according to the characterizing part of claim 1.
  • the miniaturization of a catheter valve to the size of the internal cross section of the catheter and the associated difficulties in industrial production are eliminated.
  • the valve is closed automatically by a simple spring-elastic mechanism after the finger pressure on the distal catheter balloon has ended. If the internal pressure in the bladder is high, the tightness of the valve closure increases.
  • Removal of the device from the urethra is accomplished by another disposable, specially designed, sterile rod that separates the distal portion of the catheter, thereby draining the fluid (e.g., water) from the balloons.
  • the device can also be removed from the urethra under the view of a cystoscope with the aid of a known foreign body forceps.
  • Both the male and the female incontinence catheter are thus of a relatively simple construction, the miniaturization of a valve accommodated in the distal catheter lumen, which is hardly technically feasible, is omitted, so that the incontinence catheter can be manufactured inexpensively as a disposable item.
  • No previously unknown technical processes are required for production.
  • the materials in question are physiologically compatible plastics based on silicone or latex, possibly with a known hydrophilic silver coating to additionally prevent germ colonization and with good tolerance to the mucous membrane, as well as monofilament surgical thread material. It is therefore possible to leave the catheter in the lower urinary tract for several weeks to months.
  • the device according to the invention consists of a tubular or tubular catheter, consisting of a proximal part 1 and a detachable distal part 2, both made of silicone, for example, the length of which is dimensioned such that its distal part 2 is in the inserted state lies within the male urethra 34 (FIG. 6) and its proximal end 3 projects into the lumen of the bladder 35 (FIG. 6).
  • a first balloon 4 is firmly connected to the outside of the catheter part 1.
  • a second (smaller) balloon 5 is fixed on the outside of the catheter part 1 at a short distance distal from it.
  • a channel 6, shown in broken lines, runs in the wall of the part 1 and opens into the interior of the proximal balloon 4 via an opening 7 provided in the catheter wall.
  • a further opening 8 opening into the balloon 4 is formed in the wall of part 1 by which also runs from a connecting channel 9 (shown in dashed lines) in the catheter wall to the middle balloon 5 and opens there into an opening 10 which has a significantly smaller cross section than the openings 7 and 8 of the proximal balloon 4. This results in a delayed filling of the balloon 5 in relation to the balloon 4 when a fluid (eg water) is introduced into the balloon 4 via channel 6.
  • a fluid eg water
  • a third balloon 11 which is connected to the wall of the part 1 and which has an opening 12 in the inside of the catheter wall through a channel 13 running proximally in the catheter wall and an opening 14 on the proximal one Catheter end 3 opens into a small half-balloon 15 which is firmly connected to the wall of part 1 and is the main component of an opening mechanism of valve opening 16.
  • the valve opening 16 is defined by sealing lips lying against one another, which are produced by an incision in the catheter end 3 and are pressed even more tightly against one another in the closed state by the internal pressure of the bladder.
  • the distal catheter part 2 is plugged onto the catheter part 1.
  • Two small-lumen plastic tubes 17 and 18 serve as plug-in connections.
  • the plastic tube 17 connects the wall channel 6 with an elastic needle valve 19 in the front of the part 2.
  • the plastic tube 18 continues a wall channel 13a starting from a needle valve 20 in the front of the part 2, which runs in the wall of part 2 and opens into an opening 21 within the balloon 11.
  • Two loose threads 22 (one thread not visible), one end of which is anchored in the wall of the connectable distal part 2 and the other end of which is anchored in the wall of the proximal part 1, create an additional loose connection between the two catheter parts 1 and 2.
  • Proximal of the distal balloon 11 there are one or two relatively large openings 23 in the Wall of part 1 for the drainage of secretions from the proximal urethra into the lumen 24 of the catheter.
  • a thread 52 is firmly anchored at the distal end of the catheter part 2, across its lumen. As explained in more detail below, the thread 52 is used to insert and remove the catheter according to the invention into or from the urethra.
  • a first balloon 4 is firmly connected to the outside of the proximal part 25.
  • a channel 6 runs from the distal end 28 of the distal catheter part 26, which continues in the wall of the proximal part 25 and opens into the interior of the proximal balloon 4 via an opening 7 provided in the wall thereof.
  • a second balloon 27 is fixedly connected to the wall of the distal catheter part 26, which, through an opening 12 provided in the catheter wall, has a channel 13 in the catheter wall and an opening 14 at the proximal end 3 of the proximal catheter part 25 the wall of the catheter part 25 firmly connected small half balloon 15 and the main component of the opening mechanism is a valve opening 16.
  • the balloon 27 is provided with two to four strip-shaped circular ones and protrusions or ribs 30 extending transversely to the longitudinal axis of the device.
  • the protrusions 30 can optionally be replaced by other structures (not shown) with the same function that change the surface of the balloon 27.
  • FIGS. 3, 4 and 5 show details and the function of the valve which drains into the catheter lumen at the proximal catheter end 3 of the male and female devices according to the invention in the same way.
  • a spring-elastic rod made of metal or plastic 32 is sunk in the longitudinal direction under an initial tension 31 closing the valve 16. Its ends are wrapped by two threads 33, which fix an approximately diamond-shaped fleece 34, which lies flat against the catheter end 3 and the half balloon 15, and is made of a tissue-compatible material.
  • the fleece 34 has a widened shape in its longitudinal center in order to prevent it from sliding off the half-balloon 15 when it bulges as described below.
  • the small half-balloon 15 is emptied by backflow of the fluid (eg water) via channel 13 into the balloon 11 or 27. Above all, this is done by the resilient restoring force of the elastic rod 32 , since the bending stress is released in this and this takes on its original shape again. The proximal catheter end 3 thereby returns to its original shape and the valve 16 is closed under pressure caused by the rod 32.
  • the fluid eg water
  • FIG. 6 shows a schematic representation of the anatomy of the male urethra 34 with a full bladder 35 with the male device according to FIG. 1 inserted into the male urethra 34, the protruding into the bladder Valve opening 16 is closed.
  • the balloon 11 serving for the hydraulic opening of the valve opening 16 lies approximately at the height of the scrotum attachment 36.
  • the sealing balloons 4 and 5 of the device are shown in the filled state above and below the region of the sphincter 37.
  • FIG. 7 shows a schematic representation of the anatomy of the female urethra 38 with a full bladder 39 with the female device according to FIG. 2 inserted into the urethra 38, the proximal part 25 (FIG. 2) with the sealing balloon 4 and the proximal end 3 in the full Bladder 39 protrudes.
  • the index finger 41 inserted into the outer opening of the vagina 40 compresses the balloon 27 of the device which can be felt through the front wall of the vagina 40 and the rear wall of the urethra 38, the symphysis 42, which is part of the bony pelvic ring, serving as an abutment.
  • the half balloon 15 of the proximal end 3 of the catheter is bulged and the valve 16 is opened, as a result of which the urine flows into the lumen of the device in the direction of the arrow.
  • FIG. 8 shows a schematic representation of the male device that has just been inserted into the male urethra 34 but has not yet been fixed, with a special, rigid or partially elastic, sterile plugged-in filling and insertion rod 43, the proximal end 3 into the bladder 35 with the balloon half 15 deflated and thus closed valve 16 protrudes.
  • the sealing balloon 4 of the proximal part 1 is already filled with fluid (e.g. water) with the aid of a syringe 45 placed on a valve 44 of the insertion rod 43, which corresponds to a known catheter valve.
  • the second sealing balloon 5 of the proximal catheter part 1 has not yet been deployed.
  • the balloon 11 After reaching the correct position of the device, the balloon 11 is filled with a few milliliters of fluid (e.g. water) in the male urethra 34 with the aid of a syringe 46 and a valve 47 of the same construction as the valve 44.
  • fluid e.g. water
  • the openings 21 and 12 in the wall of the proximal catheter part 1 within the balloon 11 can have a different cross section such that the opening 12 has a somewhat smaller cross section than has the opening 21.
  • FIG. 9 shows a schematic representation of a partial view of the distal part of the male device according to FIG. 1 in the male urethra 34 at the moment the insertion rod 43 is detached from the distal part 2 of the device after the balloons 4, 5 and 11 (FIGS. 8 and 1) after the injection of fluid (eg water) via the valves 44 and 47 through cannula-like extensions 48 and 49 of the guide rod 43 provided with a round tip and through the elastic needle valves 19 and 20 in the distal part 2 of the device. (Balloons 4 and 5 not shown)
  • fluid eg water
  • the shoulder formed by the latter has a notch 51 which receives the thread 52. Dislocation of the device during the extraction of the guide rod 43 due to the need for the needles 48 and 49 of the guide rod 43 in the branch valves 19 and 20, which is necessary at the beginning of the positioning of the device in the male urethra 34, to be achieved by light pressure on the outer end 50 a of the core rod 50 avoided.
  • the female device according to FIG. 2 is positioned in the female urethra 38, FIG. 7 in the same way (not illustrated) with the aid of an identical, possibly somewhat shorter insertion rod 43 according to FIG. 8.
  • FIG. 10 and 11 show a schematic representation of a partial view of the male device according to FIG. 1 during the process of removal from the male urethra 34.
  • a special rigid or partially elastic sterile extraction rod 53 is used with its end, which has a rounded, harpoon-like extension 54 is provided, first pushed blindly into the male urethra 34 and then into the open lumen 24 of the distal part 2 of the device.
  • the extraction rod 53 is subsequently withdrawn one of two or more rounded barbs 55 of the extension 54 receives the thread 52 anchored transversely to the lumen of the distal part 2 and firmly in the wall thereof.
  • the distal part 2 is released from the proximal part 1 of the device by a further pull on the extraction rod 53 (the pulling direction is shown in FIG. 11 by an arrow).
  • the two plastic tubes 17 and 18 are extracted from the lumens of the wall channels 6 and 13, as a result of which the balloons 4, 5 and 11 pass into the lumen via the openings of the channels 6 and 13 in the wall of the proximal part 1 of the device which are thereby released drain urethra 34 (shown by arrows).
  • Parts 1 and 2 remain connected by the two exciting threads 22, which are firmly anchored in the walls of parts 1 and 2.
  • FIG. 12 shows a schematic representation of a partial view of the female device according to FIG. 2 during the process of extraction from the female urethra 38.
  • the two balloons 27 and 4 filled with fluid deflate via the plastic tube 18 which partially forms the wall channel 13 and is firmly connected to part 26 of the device or the lumen of the wall channel 6 of the proximal part 25 of the device which is open at the same time as a result (shown by arrows) in FIG the female urethra 38.
  • the female device is removed from the female urethra 38 by a further pull on the extraction rod 53 (the direction of pull is shown by the arrow).
  • the emptying of the balloons 4, 5 and 11 or 4 and 27 required for the extraction can also be achieved via a modified construction, which is not shown in the drawings.
  • this construction it is provided that the associated channels 6 and 13 are accessible via a "window" which is directed towards the lumen of the catheter and is expediently attached to the distal end of the catheter and which can be destroyed in a targeted manner for the purpose of extraction.
  • This window can be an opening closed by a membrane until it is destroyed by means of a probe or foreign body forceps.
  • the invention is not limited to the embodiment of the valve 16 at the catheter end 3 which is realized by an incision. Rather, all valves are conceivable that release an inlet opening by hydraulic actuation at the catheter end 3. Furthermore, it can be thought of to protect the fleece 34 serving as a transmission element, which opens the valve 16 by bending the spring-elastic rod 32, by means of a membrane or the like from adverse effects of the urine. Such a membrane can largely surround the catheter end 3 in the area of the fleece 34, but without exerting any mechanical reaction thereon. Instead of the fleece 34, any surgical material can be used which is capable of transmitting a tensile force to the resilient rod 32 without noticeable elastic expansion.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
EP97108525A 1996-05-28 1997-05-27 Dispositif de traitement des troubles pour vider la vessie chez l'homme et la femme Expired - Lifetime EP0810001B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19621420 1996-05-28
DE19621420A DE19621420C2 (de) 1996-05-28 1996-05-28 Vorrichtung zur Behandlung von Harnblasen-Entleerungsstörungen des Mannes und der Frau
US08/864,367 US6119697A (en) 1996-05-28 1997-05-28 Device for the treatment of male and female urinary incontinence

Publications (2)

Publication Number Publication Date
EP0810001A1 true EP0810001A1 (fr) 1997-12-03
EP0810001B1 EP0810001B1 (fr) 2008-10-08

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EP97108525A Expired - Lifetime EP0810001B1 (fr) 1996-05-28 1997-05-27 Dispositif de traitement des troubles pour vider la vessie chez l'homme et la femme

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Country Link
US (1) US6119697A (fr)
EP (1) EP0810001B1 (fr)
DE (1) DE19621420C2 (fr)
ES (1) ES2316155T3 (fr)

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CN106975142B (zh) * 2017-03-16 2022-07-22 沭阳县人民医院 一种膜片式气囊导尿管
CN111107812A (zh) 2017-09-19 2020-05-05 C·R·巴德股份有限公司 导尿管桥接设备、系统及其方法
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CN113171543A (zh) * 2021-04-23 2021-07-27 上海心玮医疗科技股份有限公司 一种同轴式多功能球囊导管及其实现方法
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DE3743139A1 (de) * 1987-12-18 1989-07-06 Helmut Dr Med Weber Katheter, beispielsweise zur herzkatheterisierung
US4932938A (en) * 1989-05-05 1990-06-12 Medical Engineering Corporation Urethral indwelling catheter with incontinence control
US5360403A (en) * 1990-05-16 1994-11-01 Lake Region Manufacturing Co., Inc. Balloon catheter with lumen occluder

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2696807A1 (fr) * 2011-04-11 2014-02-19 Floelle Inc. Appareil et procédé pour inhiber l'incontinence urinaire de stress
EP2696807A4 (fr) * 2011-04-11 2014-12-17 Floelle Inc Appareil et procédé pour inhiber l'incontinence urinaire de stress

Also Published As

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US6119697A (en) 2000-09-19
DE19621420C2 (de) 1998-12-03
EP0810001B1 (fr) 2008-10-08
ES2316155T3 (es) 2009-04-01
DE19621420A1 (de) 1997-12-11

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